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510(k) Data Aggregation
K Number
K241454Device Name
Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)
Manufacturer
Guangzhou Hehong Biotech Co., Ltd.
Date Cleared
2025-02-03
(257 days)
Product Code
MQK
Regulation Number
884.6160Why did this record match?
Applicant Name (Manufacturer) :
Guangzhou Hehong Biotech Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Minvitro® Vitrification Straw (MVT-VSN series: MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) is a cryopreservation storage device intended for use in vitrification procedures to contain and maintain human oocytes (MII), 4-8 cell embryos, and blastocyst stage embryos.
Device Description
The Minvitro® Vitrification Straw (MVT-VSN series: MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) are intended for use in closed vitrification procedures to contain and maintain human oocytes (MI), 4-8 cell embryos, and blastocyst stage embryos, and they are intended for use in professional healthcare facilities. The subject devices are for single use, disposable and supplied sterile.
The Minvitro® Vitrification Straws (MVT-VSN series: MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) are all composed of a cap with a balancing head, a handle, a carrier sheet with a fine tip at the end. The oocytes or embryos are loaded on the carrier sheet, and in which, the fine tip of carrier sheet is flat with a triangular-shaped area for oocyte/embryo loading. The subject devices are sterilized using ethylene oxide (EO) to a sterilization assurance level of 106, are singleuse, and have a 2-year shelf-life.
The subject devices are available in five colors: MVT-VSNR. MVT-VSNY. MVT-VSNB. MVT-VSNG, and MVT-VSNP corresponding to Red, Yellow, Blue, Green, and Purple, respectively, all identical in size.
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